NCT00390039

Brief Summary

Multiple-center, multiple-dose, randomized, double-blind, six-arm, active- and placebo-controlled study in patients with moderate to severe post-surgical pain from elective orthopedic surgery with safety observed for a total of 30 hours post first dose.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
256

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started May 2006

Shorter than P25 for phase_3

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2006

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 17, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 19, 2006

Completed
Last Updated

January 14, 2008

Status Verified

January 1, 2008

Enrollment Period

4 months

First QC Date

October 17, 2006

Last Update Submit

January 11, 2008

Conditions

Pain, Postoperative

Keywords

Pain, postoperativeSurgery, orthopedicMorphine

Outcome Measures

Primary Outcomes (1)

  • Sum of the Pain Intensity Differences (SPID) over 0-24 hours based on Visual Analog Scale (VAS)

    Multiple

Secondary Outcomes (1)

  • Other measures of pain

    Multiple

Study Arms (6)

A

EXPERIMENTAL

MNS075 7.5mg

Drug: Intranasal Morphine

B

PLACEBO COMPARATOR

Placebo

Drug: Placebo

C

ACTIVE COMPARATOR

IV Morphine

Drug: IV morphine

E

EXPERIMENTAL

MNS075 15mg

Drug: Intranasal morphine

D

PLACEBO COMPARATOR

Placebo

Drug: Placebo

F

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Intranasal morphineDRUG

MNS075 7.5mg q1h PRN

A
PlaceboDRUG

IN Placebo q1h PRN

B
IV morphineDRUG

IV morphine 7.5mg q3h PRN

C

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Over 18 years old
  • Scheduled (within two weeks of the screening visit) to undergo elective orthopedic surgery (e.g., bunionectomy, arthroscopic knee surgery, rotator cuff repair)
  • Moderate to severe pain within 8 hours following completion of the required surgery

You may not qualify if:

  • Previous anaphylactic or serious allergic reaction to shellfish or opioids
  • History of sleep apnea

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Arizona Research Center

Phoenix, Arizona, 85023, United States

Location

HOPE Research Institute

Phoenix, Arizona, 85050, United States

Location

Vertex Clinical Research

Bakersfield, California, 93311, United States

Location

University Orthopedics Center

State College, Pennsylvania, 16801, United States

Location

SCIREX Corporation

Austin, Texas, 78705, United States

Location

SCIREX Corporation

San Marcos, Texas, 78666, United States

Location

Jean Brown Research

Salt Lake City, Utah, 84124, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Morphine

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Morphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Study Officials

  • Javelin Pharmaceuticals

    Javelin Pharmacueticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 17, 2006

First Posted

October 19, 2006

Study Start

May 1, 2006

Primary Completion

September 1, 2006

Study Completion

September 1, 2006

Last Updated

January 14, 2008

Record last verified: 2008-01

Locations

US(7)